21 CFR Part 882
PART 882—NEUROLOGICAL DEVICES
- PART 882—NEUROLOGICAL DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 882.1 Scope.
- § 882.3 Effective dates of requirement for premarket approval.
- § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- Subpart B—Neurological Diagnostic Devices
- § 882.1020 Rigidity analyzer.
- § 882.1030 Ataxiagraph.
- § 882.1200 Two-point discriminator.
- § 882.1240 Echoencephalograph.
- § 882.1275 Electroconductive media.
- § 882.1310 Cortical electrode.
- § 882.1320 Cutaneous electrode.
- § 882.1330 Depth electrode.
- § 882.1340 Nasopharyngeal electrode.
- § 882.1350 Needle electrode.
- § 882.1400 Electroencephalograph.
- § 882.1410 Electroencephalograph electrode/lead tester.
- § 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
- § 882.1430 Electroencephalograph test signal generator.
- § 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
- § 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
- § 882.1455 Traumatic brain injury eye movement assessment aid.
- § 882.1460 Nystagmograph.
- § 882.1470 Computerized cognitive assessment aid.
- § 882.1471 Computerized cognitive assessment aid for concussion.
- § 882.1480 Neurological endoscope.
- § 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.
- § 882.1500 Esthesiometer.
- § 882.1525 Tuning fork.
- § 882.1540 Galvanic skin response measurement device.
- § 882.1550 Nerve conduction velocity measurement device.
- § 882.1560 Skin potential measurement device.
- § 882.1561 Evoked photon image capture device.
- § 882.1565 Brain temperature measurement system.
- § 882.1570 Powered direct-contact temperature measurement device.
- § 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
- § 882.1610 Alpha monitor.
- § 882.1620 Intracranial pressure monitoring device.
- § 882.1630 Cranial motion measurement device.
- § 882.1700 Percussor.
- § 882.1750 Pinwheel.
- § 882.1790 Ocular plethysmograph.
- § 882.1825 Rheoencephalograph.
- § 882.1835 Physiological signal amplifier.
- § 882.1845 Physiological signal conditioner.
- § 882.1855 Electroencephalogram (EEG) telemetry system.
- § 882.1870 Evoked response electrical stimulator.
- § 882.1880 Evoked response mechanical stimulator.
- § 882.1890 Evoked response photic stimulator.
- § 882.1900 Evoked response auditory stimulator.
- § 882.1925 Ultrasonic scanner calibration test block.
- § 882.1935 Near Infrared (NIR) Brain Hematoma Detector.
- § 882.1950 Tremor transducer.
- Subparts C-D [Reserved]
- Subpart E—Neurological Surgical Devices
- § 882.4030 Skull plate anvil.
- § 882.4060 Ventricular cannula.
- § 882.4100 Ventricular catheter.
- § 882.4125 Neurosurgical chair.
- § 882.4150 Scalp clip.
- § 882.4175 Aneurysm clip applier.
- § 882.4190 Clip forming/cutting instrument.
- § 882.4200 Clip removal instrument.
- § 882.4215 Clip rack.
- § 882.4250 Cryogenic surgical device.
- § 882.4275 Dowel cutting instrument.
- § 882.4300 Manual cranial drills, burrs, trephines, and their accessories
- § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
- § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
- § 882.4325 Cranial drill handpiece (brace).
- § 882.4360 Electric cranial drill motor.
- § 882.4370 Pneumatic cranial drill motor.
- § 882.4400 Radiofrequency lesion generator.
- § 882.4440 Neurosurgical headrests.
- § 882.4460 Neurosurgical head holder (skull clamp).
- § 882.4500 Cranioplasty material forming instrument.
- § 882.4525 Microsurgical instrument.
- § 882.4535 Nonpowered neurosurgical instrument.
- § 882.4545 Shunt system implantation instrument.
- § 882.4560 Stereotaxic instrument.
- § 882.4565 Field generator positioning device.
- § 882.4600 Leukotome.
- § 882.4650 Neurosurgical suture needle.
- § 882.4700 Neurosurgical paddie.
- § 882.4725 Radiofrequency lesion probe.
- § 882.4750 Skull punch.
- § 882.4800 Self-retaining retractor for neurosurgery.
- § 882.4840 Manual rongeur.
- § 882.4845 Powered rongeur.
- § 882.4900 Skullplate screwdriver.
- § 882.4950 Diagnostic neurosurgical microscope filter.
- Subpart F—Neurological Therapeutic Devices
- § 882.5030 Methyl methacrylate for aneurysmorrhaphy.
- § 882.5050 Biofeedback device.
- § 882.5060 Conditioning tool for eating disorders.
- § 882.5070 Bite block.
- § 882.5150 Intravascular occluding catheter.
- § 882.5175 Carotid artery clamp.
- § 882.5200 Aneurysm clip.
- § 882.5225 Implanted malleable clip.
- § 882.5235 Aversive conditioning device.
- § 882.5250 Burr hole cover.
- § 882.5275 Nerve cuff.
- § 882.5300 Methyl methacrylate for cranioplasty.
- § 882.5320 Preformed alterable cranioplasty plate.
- § 882.5330 Preformed nonalterable cranioplasty plate.
- § 882.5360 Cranioplasty plate fastener.
- § 882.5500 Lesion temperature monitor.
- § 882.5550 Central nervous system fluid shunt and components.
- § 882.5560 Cerebrospinal fluid shunt system.
- § 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
- § 882.5700 Thermal system for insomnia.
- § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions.
- § 882.5800 Cranial electrotherapy stimulator.
- § 882.5801 Computerized behavioral therapy device for psychiatric disorders.
- § 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
- § 882.5803 Digital therapy device for Attention Deficit Hyperactivity Disorder.
- § 882.5804 Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.
- § 882.5805 Repetitive transcranial magnetic stimulation system.
- § 882.5808 Transcranial magnetic stimulator for headache.
- § 882.5810 External functional neuromuscular stimulator.
- § 882.5820 Implanted cerebellar stimulator.
- § 882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
- § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
- § 882.5850 Implanted spinal cord stimulator for bladder evacuation.
- § 882.5855 Brain stimulation programming planning software.
- § 882.5860 Implanted neuromuscular stimulator.
- § 882.5870 Implanted peripheral nerve stimulator for pain relief.
- § 882.5880 Implanted spinal cord stimulator for pain relief.
- § 882.5887 External lower extremity nerve stimulator for Restless Legs Syndrome.
- § 882.5888 Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
- § 882.5889 Electrical tongue nerve stimulator to treat motor deficits.
- § 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
- § 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
- § 882.5892 External vagal nerve stimulator for headache.
- § 882.5893 Thermal vestibular stimulator for headache.
- § 882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
- § 882.5895 Vibratory counter-stimulation device.
- § 882.5896 Percutaneous nerve stimulator for substance use disorders.
- § 882.5897 External upper limb tremor stimulator.
- § 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
- § 882.5899 Trunk and limb electrical stimulator to treat headache.
- § 882.5900 Preformed craniosynostosis strip.
- § 882.5910 Dura substitute.
- § 882.5940 Electroconvulsive therapy device.
- § 882.5950 Neurovascular embolization device.
- § 882.5955 Temporary coil embolization assist device.
- § 882.5960 Skull tongs for traction.
- § 882.5970 Cranial orthosis.
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